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Endothelial Progenitor Cells

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ClinicalTrials.gov Identifier: NCT01686269
Recruitment Status : Unknown
Verified January 2007 by Far Eastern Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : September 18, 2012
Last Update Posted : September 18, 2012
Sponsor:
Information provided by:
Far Eastern Memorial Hospital

Brief Summary:
Vascular stenosis as a result of neointimal hyperplasia is a major clinical problem that has an impact on multiple and diverse disciplines, including cardiology (coronary restenosis), cardiothoracic and vascular surgery (saphenous vein and polytetrafluoroethylene [PTFE] graft failure), neurology (carotid stenosis), nephrology (dialysis access dysfunction), and transplant medicine (chronic allograft rejection in hearts and kidneys). [1] In marked contrast to the deleterious effects of smooth muscle progenitor cells on neointimal hyperplasia, circulating endothelial progenitor cells (EPCs) are believed to play an important role in vascular repair and in the inhibition of neointimal hyperplasia. [2] Endothelial progenitor cells (EPCs) circulate in adult peripheral blood and contribute to neovascularization. Satoshi et al. have demonstrated that lineage-committed EPCs and CD34-positive mononuclear cells, their putative precursors, are mobilized during an acute ischemic event in humans. [3] Reduced levels of circulating EPCs independently predict atherosclerotic disease progression, thus supporting an important role for endogenous vascular repair to modulate the clinical course of coronary artery disease. [4] These observations prompt the hypothesis that circulating EPCs may provide an endogenous repair mechanism to counteract surgery-induced endothelial cell injury and to replace dysfunctional endothelium perioperatively. Therefore, the investigators examined whether levels of circulating EPCs correlate with time course and outcomes of coronary artery bypass surgery to establish a clinical role of endogenous endothelial repair mediated by circulating EPCs.

Condition or disease Intervention/treatment
Coronary Artery Disease Procedure: blood collecting

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Mobilization of Endothelial Progenitor Cells in Patients With Coronary Artery Bypass Surgery
Study Start Date : March 2007

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U.S. FDA Resources





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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age from 18 to 85 years
  • signed written informed consent
  • angiographically documented coronary artery disease and indicated for coronary artery bypass surgery

Exclusion Criteria:

  • clinical or biochemical evidence for the presence of concomitant inflammatory disease
  • chronic renal insufficiency (serum creatinine > 1.4 mmol/L)
  • impaired left ventricular ejection fraction (< 45%)
  • autoimmune or malignant disease
  • thrombocytopenia (< 100 000/L)
  • anemia (hemoglobin < 8.5 g/dL)
  • inability to understand the consent form
  • previous coronary bypass surgery
  • severe peripheral arterial occlusive disease or atrial fibrillation

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01686269


Contacts
Contact: Kuan-MIng Chiu, MD 886-2-89667000 kmchius@yahoo.com.tw

Locations
Taiwan
Far Eastern Memorial Hospital Recruiting
Taipei, Taiwan, 220
Contact: Kuan-Ming Chiu, MD    886-2-89667000    kmchius@yahoo.com.tw   
Principal Investigator: Kuan-Ming Chiu, MD         
Sponsors and Collaborators
Far Eastern Memorial Hospital
Investigators
Study Director: Kuan-Ming Chiu, MD Far Eastern Memorial Hospital

ClinicalTrials.gov Identifier: NCT01686269     History of Changes
Other Study ID Numbers: FEMH-95-C-018
First Posted: September 18, 2012    Key Record Dates
Last Update Posted: September 18, 2012
Last Verified: January 2007

Keywords provided by Far Eastern Memorial Hospital:
Endothelial progenitor cell
coronary artery bypass

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases